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Wireless Pressure Sensors in Endovascular Aneurysm Repair

Policy Number: MP-488

 

Date: January 2022

Category: Surgery

​​​​​POLICY:

Use of wireless pressure sensors is considered investigational in the management (intraoperative and/or postoperative) of patients having endovascular aneurysm repair.

DESCRIPTION OF PROCEDURE OR SERVICE:

Wireless sensors implanted in an aortic aneurysm sac after endovascular repair are being investigated to measure post-procedural pressure. It is thought that low pressures may correlate with positive prognoses, and high pressures may indicate the need for revision.

The goal of abdominal aortic aneurysm (AAA) repair is to reduce pressure in the aneurysm sac and thus prevent rupture. Failure to exclude the aneurysm completely from the systemic circulation results in continued pressurization. An endoleak (persistent perfusion of the aneurysmal sac) may be primary (within the first 30 days) or secondary (after 30 days). Endoleaks are reported to vary from 10–50% of cases, and there are 5 types of endoleaks. Type I endoleaks result from ineffective fixation at either end of the graft; while these can seal spontaneously, risk of rupture is high and intervention is often indicated. Type II endoleaks result from retrograde filling of the aneurysm mainly from lumbar and/or inferior mesenteric arteries. Risk of rupture is less than with Types I and III, and Type II endoleaks can often be monitored when the aneurysm is shrinking. Type III endoleaks are caused by failure of the implanted graft and include development of holes, which need to be treated aggressively. Type IV endoleaks are caused by the porosity of the graft fabric. Type V endoleaks are referred to as endotension and correspond to continued aneurysm expansion in the absence of a confirmed endoleak. Endoleaks, particularly Types I and III, lead to continued sac pressurization and therefore may be considered technical failures of endovascular aneurysm repair (EVAR).

The completeness of exclusion or absence of endoleaks is evaluated by intraoperative angiography. However, interpretation of images can be problematic, and it can also cause patient morbidity due to the dye load from repeated injections of contrast material. Direct measurement of sac pressure provides a physiologic assessment of success. Studies have used direct sac pressure measurements with a catheter; the drawback of this approach is the interference by the catheter during endovascular repair and the inability to leave it in place. Since endoleaks may also develop subsequent to the time of surgery, magnetic resonance imaging (MRI), and ultrasound are used in monitoring the aneurysmal sac. Percutaneous catheter-based approaches can also be used to measure intrasac pressures postoperatively.

Several factors determine aneurysm sac pressure after EVAR. These include graft-related factors, such as endoleak, graft porosity, and graft compliance and anatomic factors, such as patency of aneurysm side branches, aneurysm morphology, and the characteristics of aneurysm thrombus.

Wireless implantable pressure-sensing devices are being evaluated to monitor pressure in the aneurysm sac. These implanted devices use various mechanisms to wirelessly transmit pressure readings to devices for measuring and recording pressure. These devices have the potential to improve outcomes for patients who have had endovascular repair. They may change the need for or the frequency of monitoring of the aneurysm sac using contrast-enhanced computed tomography (CT) scans and may improve postoperative monitoring. However, the accuracy of these devices must be determined, and potential benefits and risks must be considered and evaluated. At present, 2 types of systems are being evaluated: radiofrequency and ultrasound-based systems.

KEY POINTS:

The most recent literature search was reviewed through January 18, 2022.

Summary of Evidence

For individuals who have received endovascular aneurysm repair who are monitored with wireless pressure sensors, the evidence consists of case series. Relevant outcomes are test accuracy and validity, resource utilization, and treatment-related morbidity. Evidence from small case series is insufficient to indicate whether use of this device improves clinical outcomes. Also, the performance over time needs to be addressed. Work is also needed to determine the type and number of devices that might best be used in monitoring given that sac compartmentalization might lead to a pressure-sensing device missing an endoleak. It also is not known whether there might be serious long-term complications from this implanted device. Furthermore, the extent to which the device can reduce imaging requirements following EVAR (via direct comparison with CT) is undetermined. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

No guidelines or position statements were identified.

U.S. Preventive Services Task Force Recommendations

Not applicable

KEY WORDS:

Abdominal Aortic Aneurysm, Pressure Sensor or Monitor, EndoSure Pressure Sensor, Abdominal Aortic Aneurysmal Sac, CardioMEMS, EndoSure, Impressure, AAA, Endovascular repair, wireless pressure sensor

APPROVED BY GOVERNING BODIES:

In October 2006, the EndoSure™ Wireless AAA Pressure Measurement System (CardioMEMS; now St. Jude Medical, Minneapolis, MN) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. FDA determined that this device was substantially equivalent to legally marketed predicate devices. The FDA labeling indications noted that the device is intended for measuring intrasac pressure during endovascular AAA repair. It also noted that it may be used as an adjunctive tool in the detection of intraoperative endoleaks. In March 2007, additional language was added, stating that the CardioMEMS device may be used to measure intrasac pressure during thoracic aortic aneurysm repair.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CODING:

CPT Codes:

As of 01/01/2018, there is no specific code for this procedure. Unlisted code 93799 could be utilized.

REFERENCES:

  1. Dias NV, Ivancev K, Malina M et al Intra-aneurysm sac pressure measurements after endovascular aneurysm repair: differences between shrinking, unchanged, and expanding aneurysms with and without endoleaks. J Vasc Surg 2004; 39(6):1229-35.

  2. Ellozy SH, Carroccio A, Lookstein RA et al Abdominal aortic aneurysm sac shrinkage after endovascular aneurysm repair: correlation with chronic sac pressure measurement. J Vasc Surg 2006; 43(1):2-7.

  3. Golzarian J, Valenti D. Endoleakage after endovascular treatment of abdominal aortic aneurysms: Diagnosis, significance and treatment. Eur Radiol 2006; 16(12):2849-57.

  4. Hoppe H, Segall JA, Liem TK et al Aortic aneurysm sac pressure measurements after endovascular repair using an implantable remote sensor: initial experience and short-term follow-up. Eur Radiol 2008; 18(5):957-65.

  5. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  6. Ohki T, Ouriel K, Silveira PG et al Initial results of wireless pressure sensing for endovascular aneurysm repair: the APEX Trial--Acute Pressure Measurement to Confirm Aneurysm Sac EXclusion. J Vasc Surg 2007; 45(2):236-42.

  7. Parsa CJ, Daneshmand MA, Lima B et al Utility of remote wireless pressure sensing for endovascular leak detection after endovascular thoracic aneurysm repair. Ann Thorac Surg 2010; 89(2):446-52.
  8. Silveira PG, Miller CW, Mendes RF et al Correlation between intrasac pressure measurements of a pressure sensor and an angiographic catheter during endovascular repair of abdominal aortic aneurysm. Clinics (Sao Paulo) 2008; 63(1):59-66.
  9. Sonesson B, Dias N, Malina M et al Intra-aneurysm pressure measurements in successfully excluded abdominal aortic aneurysm after endovascular repair. J Vasc Surg 2003; 37(4):733-8.

POLICY HISTORY:

Medical Policy Group (3), October 2011

Medical Policy Administration Committee, October 2011

Available for comment November 11 through December 27, 2011

Medical Policy Group, October 2012 (3): Policy review, no new literature identified. Policy statement remains unchanged.

Medical Policy Panel December 2013

Medical Policy Group December 2013 (4): Updated Key points. No change in policy statement at this time.

Medical Policy Panel, December 2014

Medical Policy Group (4): Updates to Key Points. No policy statement change.

Medical Policy Panel, June 2016

Medical Policy Group, July 2016 (4): Updates to Key Points, Key Words, Approved Governing Bodies, and References. No change to policy statement. Effective July 14, 2016, this policy is no longer scheduled for regular literature reviews and updates.

Medical Policy Group, December 2017: Annual Coding Update 2018. Created Previous Coding section and moved deleted CPT codes 34806 and 93982 to this section. Added existing code 93799 to Current coding.

Medical Policy Group, November 2019 (4): Updates to Key Points. No change to policy statement.

Medical Policy Group, December 2020 (4): Reviewed by consensus. No change to policy statement.

Medical Policy Group, January 2022 (4): Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Policy statement updated to remove “not medically necessary,” no change to policy intent. Removed deleted CPT codes effective 12/31/17 - 34806 and 93982.

 

 

 

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.